Is MDMA therapy successful with PTSD?
Psychedelics: From Intoxicants to Remedies
The substances »activate a therapeutic, dream-like state and intensify sensory perception. Memories then emerge like little films, «explains Franz Vollenweider, psychiatrist and neurochemist at the Psychiatric University Clinic in Zurich. He believes that this state of mind helps people break out of rigid thought patterns that resemble Rutter's negative spiral of thought. The receptive state in which the psychedelics place the patient opens the door to new ideas about how to look at one's past and future. A therapist can then take up these findings and reinforce them.
The journey Rutter embarked on with Carhart-Harris was focused but flexible. The first time Rutter took off his eye mask after the drug began to work, the therapist looked "fractured" to him. He also had a third eye in the middle of his forehead. "I imagine I'm looking strange to you now," Carhart-Harris said. Rutter burst out laughing, and Carhart-Harris joined in. Then the two men started talking. Rutter wanted to talk about his resentment and bitterness, which led him to start thinking about the word "give in" and its etymology. Carhart-Harris researched it for him on his laptop. "That was a nice moment," says Rutter. He later came back to the clinic for a second session with a stronger dose of the drug. He also completed a second MRI scan and an "integration session" in which he talked to the therapist about his experiences during the drug intoxication. The treatment "made me see my grief and grief differently," says Rutter. "I came to the realization that neither of these things helped me and that letting go is not betrayal."
Studying the therapeutic potential of drugs like psilocybin and ultimately deciding how to treat it is tricky. The world is currently looking primarily at two studies. One is a recently completed Phase III study of MDMA that was tested against severe post-traumatic stress disorder. The substance is known, among other things, to increase mood and enhance the perception of one's own feelings. A total of 90 volunteers at 15 locations around the world took part in the experiment. The Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit organization in San José, California, funded the study, but has not yet published the results. The healthcare company COMPASS Pathways in London, on the other hand, is currently conducting a Phase IIb study in which various doses of psilocybin are being tested in treatment-resistant depression.
Phases of clinical trials
When a new drug is developed, it goes through five clinical phases. In order to be able to carry out a study in a higher phase, all previous phases must have been successfully completed.
Phase 0 study: The first experiments on healthy people take place. About 10 to 15 people receive sub-therapeutic doses, also known as microdosing. The main focus is on examining how the active ingredient behaves in the body.
Phase I study: About 20 to 80 people receive a dose that could be relevant for later therapeutic use. It is checked how tolerable and safe the remedy is.
Phase II study: The manufacturers review the therapy concept with around 50 to 200 people and determine a suitable dose. At this point in time, the positive effects of the therapy should already be visible.
Phase III study: Now it is decided whether the responsible authorities will approve a drug. The therapeutic effectiveness of the drug must be proven on 200 to 10,000 people. This also applies to its safety, an appropriate pharmaceutical quality and a suitable risk-benefit ratio.
Phase IV study: These long-term follow-ups begin after the drug is approved. This is intended, for example, to detect very rare side effects that are only visible in very large patient populations.
Evaluating the results will not be easy. On the one hand, this is because it is difficult to blindly blind studies with drugs - i.e. to ensure that neither the participants nor the doctors involved know who is receiving the real active ingredient and who is only receiving a placebo. Most people who swallow a placebo pill will be able to guess that they have not received a potent hallucinogen. Some research groups try to solve this problem by giving participants in the control group a pill with niacin that induces at least certain physical reactions.
In addition, the researchers have to deal with the extent to which the accompanying circumstances influence the success of drug-assisted psychotherapy. These include, for example, the attitudes of the participants and the environment in which the experiments take place. In the treatment rooms of the COMPASS study at the Utrecht University Medical Center in the Netherlands, for example, there is a spa atmosphere: a Mexican-style blanket adorns each of the large double beds on which the test subjects sit for the treatment. Beanbags surround a palm tree in the corner, and a poster of Van Gogh's "Almond Blossom" hangs on the wall.
In addition, there is the training and experience of the therapists who lead both the drug-free sessions and the drug-free integration sessions. COMPASS has specially developed a five-stage training program for the specialists who accompany the patients as part of the study.
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